FDA wants more Remoxy info from Pain Therapeutics

WilliamSpain

CHICAGO (MarketWatch) -- Pain Therapeutics said Thursday that it has received a letter from the Food and Drug Administration telling the company that its new drug application for Remoxy, a controlled-release version of oxycodone, will not be approved in its present form. The FDA told Pain Therapeutics
PTIE, +1.54%
that more non-clinical data is needed to support approval of the drug but is not asking for more clinical efficacy studies. The company and its partner, King Pharmaceuticals
KG, +0.00%
are evaluating the letter and "will provide an update when appropriate," Pain Therapeutics said.

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